Determination and Selection of the Optimum Number of Sites and Patients for Clinical Studies

1992 ◽  
Vol 71 (8) ◽  
pp. 1516-1521 ◽  
Author(s):  
P.P. Hujoel ◽  
T.A. DeRouen
2015 ◽  
Vol 12 (4) ◽  
pp. 69-74
Author(s):  
O D Ostroumova ◽  
V M Fomina ◽  
E A Smolyarchuk

In the article discusses questions of application of b-blockers (b-AB) for the treatment of arterial hypertension, coronary heart disease, chronic heart failure. The data from modern Russian and European recommendations about the place of b-AB in the treatment of cardiovascular diseases. Analyzed in detail the selection of b-AB inside the class from the standpoint of pharmacokinetics, selectivity, study in clinical studies. Data about efficiency and safety of application of metoprolol succinate for the treatment of arterial hypertension, coronary heart disease, chronic heart failure.


Symmetry ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 2099
Author(s):  
Divo Dharma Silalahi ◽  
Habshah Midi ◽  
Jayanthi Arasan ◽  
Mohd Shafie Mustafa ◽  
Jean-Pierre Caliman

With the complexity of Near Infrared (NIR) spectral data, the selection of the optimal number of Partial Least Squares (PLS) components in the fitted Partial Least Squares Regression (PLSR) model is very important. Selecting a small number of PLS components leads to under fitting, whereas selecting a large number of PLS components results in over fitting. Several methods exist in the selection procedure, and each yields a different result. However, so far no one has been able to determine the more superior method. In addition, the current methods are susceptible to the presence of outliers and High Leverage Points (HLP) in a dataset. In this study, a new automated fitting process method on PLSR model is introduced. The method is called the Robust Reliable Weighted Average—PLS (RRWA-PLS), and it is less sensitive to the optimum number of PLS components. The RRWA-PLS uses the weighted average strategy from multiple PLSR models generated by the different complexities of the PLS components. The method assigns robust procedures in the weighing schemes as an improvement to the existing Weighted Average—PLS (WA-PLS) method. The weighing schemes in the proposed method are resistant to outliers and HLP and thus, preserve the contribution of the most relevant variables in the fitted model. The evaluation was done by utilizing artificial data with the Monte Carlo simulation and NIR spectral data of oil palm (Elaeis guineensis Jacq.) fruit mesocarp. Based on the results, the method claims to have shown its superiority in the improvement of the weight and variable selection procedures in the WA-PLS. It is also resistant to the influence of outliers and HLP in the dataset. The RRWA-PLS method provides a promising robust solution for the automated fitting process in the PLSR model as unlike the classical PLS, it does not require the selection of an optimal number of PLS components.


Molecules ◽  
2019 ◽  
Vol 24 (19) ◽  
pp. 3593 ◽  
Author(s):  
Yoko Yagishita ◽  
Jed W. Fahey ◽  
Albena T. Dinkova-Kostova ◽  
Thomas W. Kensler

There is robust epidemiological evidence for the beneficial effects of broccoli consumption on health, many of them clearly mediated by the isothiocyanate sulforaphane. Present in the plant as its precursor, glucoraphanin, sulforaphane is formed through the actions of myrosinase, a β-thioglucosidase present in either the plant tissue or the mammalian microbiome. Since first isolated from broccoli and demonstrated to have cancer chemoprotective properties in rats in the early 1990s, over 3000 publications have described its efficacy in rodent disease models, underlying mechanisms of action or, to date, over 50 clinical trials examining pharmacokinetics, pharmacodynamics and disease mitigation. This review evaluates the current state of knowledge regarding the relationships between formulation (e.g., plants, sprouts, beverages, supplements), bioavailability and efficacy, and the doses of glucoraphanin and/or sulforaphane that have been used in pre-clinical and clinical studies. We pay special attention to the challenges for better integration of animal model and clinical studies, particularly with regard to selection of dose and route of administration. More effort is required to elucidate underlying mechanisms of action and to develop and validate biomarkers of pharmacodynamic action in humans. A sobering lesson is that changes in approach will be required to implement a public health paradigm for dispensing benefit across all spectrums of the global population.


2021 ◽  
Vol 8 ◽  
Author(s):  
Jed W. Fahey ◽  
Thomas W. Kensler

Broccoli sprouts are a convenient and rich source of the glucosinolate glucoraphanin, which can generate the chemopreventive agent sulforaphane through the catalytic actions of plant myrosinase or β-thioglucosidases in the gut microflora. Sulforaphane, in turn, is an inducer of cytoprotective enzymes through activation of Nrf2 signaling, and a potent inhibitor of carcinogenesis in multiple murine models. Sulforaphane is also protective in models of diabetes, neurodegenerative disease, and other inflammatory processes, likely reflecting additional actions of Nrf2 and interactions with other signaling pathways. Translating this efficacy into the design and implementation of clinical chemoprevention trials, especially food-based trials, faces numerous challenges including the selection of the source, placebo, and dose as well as standardization of the formulation of the intervention material. Unlike in animals, purified sulforaphane has had very limited use in clinical studies. We have conducted a series of clinical studies and randomized clinical trials to evaluate the effects of composition (glucoraphanin-rich [± myrosinase] vs. sulforaphane-rich or mixture beverages), formulation (beverage vs. tablet) and dose, on the efficacy of these broccoli sprout-based preparations to evaluate safety, pharmacokinetics, pharmacodynamic action, and clinical benefit. While the challenges for the evaluation of broccoli sprouts in clinical trials are themselves formidable, further hurdles must be overcome to bring this science to public health action.


2020 ◽  
Author(s):  
Irfan Aygün ◽  
Mehmet Kaya ◽  
Reda Alhajj

Abstract To increase the success in Covid 19 treatment, many drug suggestions are presented, and some clinical studies are shared in the literature. There have been some attempts to use some of these drugs in combination. However, using more than one drug together may cause serious side effects on patients. Therefore, detecting drug-drug interactions of the drugs used will be of great importance in the treatment of Covid 19. In this study, the interactions of 8 drugs used for Covid 19 treatment with 645 different drugs and possible side effects estimates have been produced using Graph Convolutional Networks. Organ systems and diseases in which these 8 drugs cause the most negative effects have been identified. In addition, as it is known that some of these 8 drugs are used together in Covid-19 treatment, the side effects caused by using these drugs together are shared. With the experimental results obtained, it is aimed to facilitate the selection of the drugs and increase the success of Covid 19 treatment according to the targeted patient.


Author(s):  
A. V. Rodin

The advantages and disadvantages of modern antiseptics for local treatment and prevention of wound infections are considered. On the basis of data of comparative clinical studies the advantages of topical drugs based on octenidine dihydrochloride in combination with phenoxyethanol are presented. The advantages of octenidine dihydrochloride/ phenoxyethanol as a local antiseptic for treatment and prevention of wound infections in case of wound defects, burns are described.


Kardiologiia ◽  
2020 ◽  
Vol 60 (10) ◽  
pp. 99-106
Author(s):  
V. A. Ionin

This review focuses on the relevance of sinus rhythm control in patients with atrial fibrillation in real-life clinical practice and specific clinical features of patients with this arrhythmia. The authors presented current guidelines on prevention of thromboembolic complications and a review of results from major clinical studies of direct oral anticoagulants. The search for literature and selection of clinical studies for 2009-2020 were performed on websites of the European and Russian Societies of Cardiology, the All-Russian Scientific Society of Arrhythmologists, and in online databases PubMed, EMBASE, eLibrary, and Google Scholar using the key words atrial fibrillation, anticoagulants, ablation, cardioversion, and efficacy and safety.


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